HT941026QE047 Redacted Justification and Approval.pdf

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MAMC Newborn Screening Services
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HT941026QE047
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This is a Justification and Approval (J&A) document for a sole-source contract award under the Revolutionary Federal Acquisition Regulation (FAR) Overhaul (RFO).

The Defense Health Agency (DHA), through its Healthcare Contracting Division (HCD) - West, is awarding a sole-source, single-award Indefinite Delivery Indefinite Quantity (IDIQ) Firm-Fixed Price (FFP) contract to the Washington State Department of Health (UEI: C16SP2HBR123, CAGE: 1FSD1, located at 101 Israel RD SE Tumwater, WA 98501-5570) to provide Newborn Screening services for Madigan Army Medical Center (MAMC). The contract will operate for 5 years with an estimated ceiling of $1,500,000.00. Newborn screening involves collecting blood specimens from newborns' heels onto filter paper cards to identify rare congenital conditions. The procurement is justified under statutory authority of 41 U.S.C. 1901 and RFO FAR 12.102-1 Simplified Procedures. The sole-source justification is based on Washington State law RCW 70.83.020, which statutorily designates the Washington State Department of Health as the sole entity authorized to administer the Newborn Screening Program, including collection, testing, and reporting. MAMC, a level-II trauma center serving over 100,000 active-duty service members and their families, delivers approximately 1,200 newborns annually and is legally required to provide newborn screening services. The Contracting Officer determined the anticipated cost to be fair and reasonable based on legislatively set prices for entities contracting with Washington State. No other sources have expressed interest in providing these services.

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Justification and Approval (J&A) for Other than Full and Open Competition

Revolutionary Federal Acquisition Regulation (FAR) Overhaul (RFO) Parts 6 and 12 Implemented by Class Deviation 2026-O0017, Revision 2

1. Identification of the Agency and Contracting Activity: Defense Health Agency (DHA), DHA Contracting Activity (DHACA), Healthcare Contracting Division (HCD) - West) on behalf of DHA to meet the requirements of Madigan Army Medical Center (MAMC) (RFO FAR 6.104- 1(a)(1)).

2. Nature and/or Description of Action being Approved: The requirement being approved is a new sole-source single-award Indefinite Delivery Indefinite Quantity (IDIQ) Firm-Fixed Price (FFP) Contract (RFO FAR 6.104-1(a)(2)).

3. Description of Supplies/Services and Estimated Value: The government requires a sole source contract award to Washington State Department of Health, UEI: C16SP2HBR123, CAGE:

1FSD1, 101 Israel RD SE Tumwater, WA 98501-5570. This sole source contract shall provide Newborn Screens through contract with the Washington State Department of Health. Newborn Screening is a Department of Health program that identifies babies born in Washington State with rare congenital conditions. A newborn screening specimen is obtained by collecting drops of blood from a baby's heel onto a special filter paper card.

The resulting IDIQ ordering period is anticipated for a period of 5 years and has an estimated contract ceiling of $1,500,00.00; notwithstanding the current government estimate for total ending contract value is shown below. (RFO FAR 6.104-1(a)(3)).

4. Statutory Authority Permitting Other Than Full and Open Competition: This procurement is in accordance with the procedures under RFO FAR 12.102-1 Simplified Procedures (See RFO FAR 12.102(b)) and is under the Statutory Authority of 41 U.S.C. 1901 (RFO FAR 6.104-1(a)(4)).

5. Rationale Justifying Use of Authority Cited: Madigan Army Medical Center (MAMC) comprises a network of Army medical facilities located on Joint Base Lewis McChord (JBLM), Washington and serves more than 100,000 active-duty service members, their families, and retirees. MAMC is a level-II trauma center and operates many departments 24 hours a day 7 days a week. One of those departments is the Labor and Delivery unit which sees expecting parents and delivers roughly 1,200 newborns annually.

In accordance with Washington State law RCW 70.83.020, the labor and delivery unit must be able to provide newborn screening. RCW 70.83.020 states: “(1) It shall be the duty of the department of health to require screening tests of all newborn infants born in any setting. Each hospital or health care provider attending a birth outside of a hospital shall collect and submit a sample blood specimen for all newborns no more than forty-eight hours following birth. The department of health shall conduct screening tests of samples for the detection of phenylketonuria and other heritable or metabolic disorders leading to intellectual disabilities or physical defects as defined by the state board of health: PROVIDED, That no such tests shall be given to any newborn infant whose parents or guardian object thereto on the grounds that such tests conflict with their religious tenets and practices.

(2) The sample required in subsection (1) of this section must be received by the department [of health] within seventy-two hours of the collection of the sample, excluding any day that the Washington state public health laboratory is closed.”

In order for MAMC to be able to deliver babies on Labor and Delivery, they have to be able to provide Newborn Screens through contract with the Washington State Department of Health.

The contractor, WA State Department of Health, has confirmed in writing, provided to the Contracting Officer’s Representative, that they are the only source IAW State Statute RCW 70.83.020, “[WA State Department of Health] is statutorily designated to administer the Newborn Screening Program, including the collection, testing, and reporting of newborn screening specimens. State law does not permit alternative laboratories to provide these services.” (RFO FAR 6.104-1(a)(5)).

6. Efforts to Obtain Competition:

7. Actions to Increase Competition/Remove or Overcome any Barriers to Competition:

8. Market Research:

9. Other Facts (RFO FAR 6.104-1(a)(9)):

a.

b. Additional Information: Not Applicable.

10. Interested Sources:

To date, no other sources have written to express an interest. (RFO FAR 6.104-1(a)(10)).

11. Technical & Requirements Certification:

I certify the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Supervisor Laboratory Department, DHA Madigan AMC

13. Legal Review:

I have reviewed this justification and have found it to be legally sufficient.

Attorney, Office of General Counsel Contract Law MTF Support Branch Defense Health Agency

14. Contracting Officer Determination of Fair and Reasonable Pricing and Certification of Accuracy and Completion.

Fair and Reasonable Cost Determination:

I hereby determine the anticipated cost to the Government for this contract action will be fair and reasonable. (RFO FAR 6.104-1(a)(7)).

Basis for Determination: The Contracting Officer will utilize the legislatively set price for all entities contracting with WA State to determine fair and reasonable.

I certify this justification is accurate and complete to the best of my knowledge and belief. (RFO FAR 6.104-1(a)(12)).

George Rutt Contracting Officer DHA, HCD-W, Delta Branch

RUTT.GEORGE. Digitally signed by

RUTT.GEORGE.

Date: 2026.09.22 12:25:40 -07'00'

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